BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RX ACCULINK CAROTID STENT SYSTEM

    MDR report key: 761509 · Received September 13, 2006

    Report

    Report Number
    3004742046-2006-00391
    Event Type
    Injury
    Date Received
    September 13, 2006
    Date of Event
    August 28, 2006
    Report Date
    August 31, 2006
    Manufacturer
    GUIDANT ENDOVASCULAR SOLUTIONS
    Product Code
    NIM
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    STUDY EVENT.

    Description of Event or Problem · 1

    DEVICE MALFUNCTION: NONE REPORTED. SYMPTOMS/AE: EXPRESSIVE APHASIA, MILD CONFUSION. TIME OF SYMPTOMS/AE: ONSET - 21 DAYS AFTER PROCEDURE. IT WAS REPORTED THAT IN 2006, 21 DAYS AFTER A LIC STENTING PROCEDURE, THE PATIENT EXPERIENCED ACUTE ONSET OF EXPRESSIVE APHASIA AND WAS ADMITTED THROUGH THE ER. THE MRI WAS NEGATIVE FOR CVA, AND TRANSCRANIAL DOPPLER MONITOR REVEALED MICROEMBOLI OF THE RIGHT MCA. THE SYMPTOMS RESOLVED AS OF 1700 ON 8/28, AND THE PATIENT WAS DISCHARGED ON THE FOLLOWING DAY. THE TREATMENT WAS PLAVIX AND LOVENOX. ONE DAY LATER, THE PATIENT WAS AGAIN ADMITTED TO THE HOSPITAL WITH EXPRESSIVE APHASIA AND MILD CONFUSION. THE MRI AND BUBBLE STUDY WERE NEGATIVE. THE EMBOLIZATION STUDY WAS POSITIVE WITH RIGHT MCA TERRITORY. THE TRANSESOPHAGEAL ENDOSCOPY WAS NEGATIVE FOR VEGETATION, CLOT OR PATENT FORAMEN OVALE. TREATMENT CONSISTED OF COUMADIN AND HEPARIN. THE PATIENT WAS DISCHARGED HOME ON 9/4/2006 ON COUMADIN. NO ADDITIONAL INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RX ACCULINK CAROTID STENT SYSTEM CAROTID STENT SYSTEM NIM GUIDANT ENDOVASCULAR SOLUTIONS NA 6072151

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Hospitalization| R OTHER: RX ACCUNET